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Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

18 Years
Open (Enrolling)
Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

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Trial Information

Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)


I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia
[AML]-like therapy), versus less intensive hypomethylation agent (HMA) as initial therapy,
on failure-free survival.


I. Determine if IC (intensive AML-like therapy) in comparison to HMA as initial therapy,
will affect transplantation frequency, quality of life, pre-hematopoietic cell
transplantation (HCT) toxicity, and transplant candidacy.

II. Conduct exploratory analysis of post-HCT outcomes (overall survival, non relapse
mortality, incidence of graft rejection, graft-versus-host disease [GVHD], relapse, and
relapse-free survival).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC)
for 7 days. Treatment repeats every 28 days for 4 courses of decitabine or 6 courses of
azacitidine in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cytarabine IV continuously over 24 hours for 7 days and idarubicin
IV or daunorubicin hydrochloride IV on days 1-3 at the discretion of the treating physician.
Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up for 18 months.

Inclusion Criteria:

- Diagnosis of de novo or secondary myelodysplastic syndrome (MDS), including chronic
myelomonocytic leukemia, as defined by the 2008 World Health Organization
classification system

- Patients must have measurable disease requiring cytoreduction, defined as a bone
marrow myeloblast count >= 5% and < 20% on morphologic examination

- Patients in which adequate marrow/biopsy specimens cannot be obtained to determine
disease burden by morphologic assessment, but have fulfilled criteria (abnormal
myeloblast count >= 5% and < 20%) by flow cytometry are still be eligible; reasonable
attempts must be made to obtain an adequate specimen for morphologic assessment,
including possible repeat procedures

- Patients must be considered to have an acceptable risk of early mortality with
intensive chemotherapy as determined by the attending physician at the time of the
initial visit; since the specific therapy within each arm will be determined after
randomization, there is no threshold of organ dysfunction or performance status for
inclusion; the attending may use metrics such as Treatment Related Mortality Score
(TRM) or Karnofsky performance status, in addition to clinical values (age, platelet
count, serum albumin, secondary or de novo disease, white blood cell count,
peripheral blood blast percentage, and serum creatinine) to determine if a patient
should be included

- Considered a potential transplant candidate; the attending physician will determine
transplant candidacy at the time of initial visit

- Human leukocyte antigen (HLA)-typing must be requested by the time of enrollment, but
does not need to be resulted to enroll

- Males should be willing to use an effective contraceptive method during the study and
for a minimum of 6 months after study treatment

- Women must be postmenopausal or must be willing to use an acceptable method of
contraception to avoid pregnancy for the entire period of the study and for at least
3 months after the study; a postmenopausal woman is defined as a woman who has
experienced amenorrhea > 12 consecutive months or a woman on hormone replacement
therapy with documented follicle-stimulating hormone (FSH) level > 35 mIU/mL; for
patients in whom menopausal state is in question, a negative pregnancy test will be
required prior to enrollment

- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent

Exclusion Criteria:

- A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health
Organization classification system

- Previous treatment for MDS or AML with intensive chemotherapy regimen (induction
chemotherapy) or hypomethylating agent; previous treatment with iron chelation,
growth factors (filgrastim [GCSF], erythropoiesis stimulating agent, or
thrombopoietin mimetics), small molecule inhibitors, or immune modulatory drugs
(thalidomide, lenalidomide) is acceptable

- Use of any anticancer therapy within 2 weeks before study entry with the exception of

- Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver, or other organ system that
may place the patient at undue risk to undergo treatment

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled
(defined as exhibiting ongoing signs/symptoms related to the infection and without
improvement, despite appropriate antibiotics or other treatment)

- Pregnant or lactating patients

- Any uncontrolled or significant concurrent disease, illness, or psychiatric disorder
that would compromise patient safety or compliance, interfere with consent, study
participation, follow up, or interpretation of study results

- Clinical evidence suggestive of central nervous system (CNS) involvement with
leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the
cerebrospinal fluid (CSF)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival (failure defined as death, lack of response to initial therapy, relapse after response to initial therapy)

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Bart Scott

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Federal Government

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Secondary Myelodysplastic Syndromes
  • myelodysplastic syndrome
  • chronic myelomonocytic leukemia
  • bone marrow transplant
  • hypomethylating agent
  • induction chemotherapy
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109